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A Safety and Efficacy Study of DRM02 in Subjects With Rosacea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993446
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

Brief Summary:
The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of rosacea when applied twice daily for 6 weeks.

Condition or disease Intervention/treatment Phase
Rosacea Drug: DRM02 Other: Vehicle Phase 2

Detailed Description:

This is a double-blind, randomized, vehicle controlled, study enrolling 30 subjects with rosacea and designed to assess the safety, tolerability, and preliminary efficacy of DRM02.

Safety will be assessed during the study, through adverse events, local skin responses, urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital signs.

Preliminary efficacy will be assessed through inflammatory lesion counts, the Investigator's Global Evaluation (IGE) and the Rosacea Signs and Symptoms (RSS) scale.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Vehicle Controlled Study of the Safety and Efficacy of Topical DRM02 in Subjects With Rosacea
Study Start Date : October 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: DRM02
DRM02 Topical Gel, 0.25%
Drug: DRM02
Placebo Comparator: Vehicle
DRM02 Topical Gel, Vehicle
Other: Vehicle



Primary Outcome Measures :
  1. Change in inflammatory lesion count [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Investigator's Global Evaluation (IGE) [ Time Frame: From baseline to weeks 0, 1, 2, 3, 4 and 6 ]
  2. IGE dichotomized into "success" and "failure" [ Time Frame: Week 6 ]
  3. Percent change in inflammatory lesions [ Time Frame: Week 6 ]

Other Outcome Measures:
  1. Rosacea Signs and Symptoms (RSS) [ Time Frame: From baseline to weeks 0, 1, 2, 3, 4 and 6 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 18 to 70 years of age.
  • Clinical diagnosis of rosacea with a score of 2 or 3 on the Investigator's Global Evaluation (IGE) of Rosacea scale and at least 15 and not more than 40 papules.
  • Subjects willing to minimize external factors that might trigger rosacea flare-ups.
  • Male or non-pregnant, non-lactating females.
  • Signed informed consent.

Exclusion Criteria:

  • Severe self-reported facial sensitivity.
  • Severe sun sensitivity.
  • Ocular-only, phymatous rosacea or steroid rosacea.
  • Use of topical rosacea treatments in the 4 weeks prior to baseline.
  • Use of systemic corticosteroids within the 4 weeks prior to baseline.
  • Use of systemic antibiotics in the 4 weeks prior to baseline.
  • Use of systemic retinoids for in the 6 months prior to baseline.
  • Use of topical retinoids in the 3 months prior to baseline.
  • Use of light- or laser-based rosacea treatments in the past 2 months prior to baseline.
  • Cosmetic procedures within the 2 months prior to baseline.
  • Use of topical anti-aging medications in the 2 weeks prior to baseline.
  • Subjects who have poor skin condition within 5 cm of the treatment area.
  • Subjects who are current drug or alcohol abusers; have a history of immunodeficiency or are a poor medical risk because of other systemic diseases or active uncontrolled infections.
  • Subjects with an unstable medical condition or a medical condition not adequately controlled with standard medical therapy.
  • Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days.
  • Subjects who have a clinically significant laboratory value at screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993446


Locations
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Canada, Ontario
Windsor Clinical Research, Inc.
Windsor, Ontario, Canada, N8W 5W7
Canada, Quebec
Clinique Médicale Dr Isabelle Delorme
Drummondville, Quebec, Canada, J2B5L4
Innovaderm Research, Inc
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Dermira, Inc.
Investigators
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Study Director: Beth Zib Dermira, Inc.
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Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT01993446    
Other Study ID Numbers: DRM02-ROS02
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Rosacea
Skin Diseases